Croatia

Croatia’s government has mostly harmonized its technical standards legislation with the EU Directives, as this was an important requirement Croatia had to fulfill to conclude the EU accession negotiations. To create an internal market where goods legally manufactured in one member state can be sold in the market of another member without any additional testing and certification, the EU is in a continuous process of harmonizing technical regulations, standards and conformity assessment procedures among the member states. Since the EU consists of independent states, the EU adopts Directives and publishes references to harmonized standards that each member state is required to transpose into its own legislation and national standards system. More detailed information on the EU standards and certification is available from the U.S. Commercial Service at the U.S. Mission to the EU in Brussels: http://export.gov/europeanunion/eustandardsandcertification/index.asp Although the Croatian representative or importer is held directly responsible for product safety and for its conformity with Croatian technical regulations, the ultimate responsibility lies with the manufacturer. Given the complexity and changeability of the technical legislation and the numerous governmental institutions involved, the U.S. Commercial Service at the American Embassy Zagreb can assist U.S. exporters to obtain current information on regulations, standards, and conformity assessment procedures related to their specific product intended for the Croatian market. Standards Organizations The Croatian Standards Institute (HZN) is the public institution responsible for preparation, adoption, editing, and publication of Croatian standards. Any legal entity or natural person with the seat or residence in Croatia may be a member of the HZN and participate in its work. The members include interested Croatian manufacturers, testing and measuring laboratories and certification bodies, educational and scientific institutions, chambers of commerce, industry associations, consumer associations, and government institutions. Only 0.2 percent of the Croatian standards are of purely Croatian origin; the rest of them are adopted European and/or international standards. HZN maintains an on-line catalog of Croatian and other standards that can be mailed to interested users for a fee. As per EU directives, the Croatian standards are voluntary. NIST Notify U.S. Service Member countries of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries. Notify U.S. is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that can affect your access to international markets. Register online at http://www.nist.gov/notifyus/

Conformity Assessment In Croatia, the Ministry (or other government institution) responsible for preparing and implementing technical regulations for specific products is also responsible for defining the related conformity assessment procedure (for example, the Ministry of Health is in charge for medicinal products, the Ministry of Construction for construction products, the Ministry of Interior for explosives, etc. and the Ministry of Economy is in charge of the products that are not under authority of any other ministry). The basic elements of the conformity assessment procedure are defined by the Law on Technical Requirements for Products and Conformity Assessment adopted in 2003 and significantly modified in July 2007. Product Certification Although the Croatian Law on General Products Safety states that all products must be safe, some products do not require certification, some can be selfcertified by the manufacturer or importer, and some require a third party certification before they can be put on the market. For products that can be self certified, a manufacturer’s or importer’s declaration of conformity is required and the accompanying technical documentation should be kept on file for ten years (all in Croatian language). When a third-party certification is required, the Ministry or other government institution in charge of that type of product designates appropriately equipped and trained private sector institutions to serve as conformity assessment bodies and authorizes them to issue certificates of conformity for that type of product. Accreditation The Croatian Accreditation Agency is the public institution that confirms to Croatian private sector laboratories, companies and physical persons that they meet certain standards required to participate in the conformity assessment process, i.e. issues them a formal accreditation. These standards are also voluntary. They serve to facilitate the evaluation by Ministry or government institution in charge of the type of product, when deciding on the applicant’s ability to be authorized as a conformity assessment body. As a part of creating the internal market, the EU has developed harmonized standards to be used for accreditation of the third parties in the conformity assessment process in order to enable creation of an EU-wide network of equally technically capable laboratories and conformity assessment bodies whose certificates are valid throughout the EU. Each member state has designated conformity assessment bodies on its own territory that meet these standards and has notified them to the EU Commission that keeps the list of Notified Bodies. Each member state is responsible for assuring the required standard quality of work of the Notified Bodies it had designated. To facilitate bilateral trade, this EU-wide network of Notified Bodies is being expanded to non-EU countries, such as EFTA countries (EEA members) and other countries (including the United States) with which the EU has concluded general Mutual Recognition Agreements (MRAs) or more detailed Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAAs). In 2007, the EU and Croatia began working on a bilateral ACAA agreement, which has been developed gradually, sector-by-sector, parallel to the EU accession negotiations process. By January 2012, preparations had been concluded for a total of six sectors (personal protection equipment - gloves, lowvoltage equipment, recreational boats, radio and telecommunication terminal equipment, electromagnetic compatibility, and gas devices) but signing of an ACAA agreement for these sectors is pending

Croatia’s full implementation of EU regulation 765/2008 on RAPEX -- EU rapid alert system for all dangerous consumer products, with the exception of food, pharmaceutical and medical devices. Publication of Technical Regulations Technical regulations are published in the Croatian Official Gazette, along with all other laws and regulations. Some technical laws and regulations have been translated into English, primarily for the needs of the EU accession process. Again, the U.S. Commercial Service at the American Embassy Zagreb can assist U.S. exporters to find out about the legislation relevant to their type of product and can also arrange for translation services, if necessary. Labeling and Marking Similar to the CE marking in the EU market, in Croatia, an official certification mark “C” is mandatory for specific products as a symbol of conformity with the applicable Croatian requirements imposed on the manufacturer. The Croatian Law on Technical Requirements for Products and Conformity Assessment does allow the Ministry or the government institution in charge of the specific type of product to recognize foreign certificates and certification marks on a case-bycase basis, but in practice this option has not been widely used. The CE marking will become automatically recognized in Croatia either when a bilateral ACAA agreement is signed with the EU (but only for the products listed in the agreement) or when Croatia becomes an EU member, whichever comes first. For the time being, imported products must be “C” marked (if the certification mark is required for that product) and must be accompanied with the manufacturer’s or importer’s declaration of conformity (in Croatian language) and with a certificate of conformity issued by a Croatian conformity assessment body (again, if required). Most of the technical regulations are enforced by the State Inspectorate, except for products for which other institutions are in charge (veterinary inspectors report to the Ministry of Agriculture, sanitary inspectors to the Ministry of Health, etc.). Contacts Croatian Standards Institute Ulica grada Vukovara 78 Zagreb, Croatia Tel: +385-1-610-6095 Fax: +385-1-610- 9321 Website: http://www.hzn.hr/ Trade Agreements Free Trade Agreements Croatia has free trade agreements with EU, EFTA countries (Norway, Iceland, Liechtenstein, and Switzerland), and with Albania, Bosnia and Herzegovina, Serbia, Montenegro, Kosovo, Macedonia, Turkey, and Moldova. Trade Relations with the European Union In October 2001, the European Union and Croatia signed a Stabilization and Association Agreement (SAA). Related to the SAA, an Interim Agreement concerning trade and transport became effective on January 1, 2002. This agreement includes the

Autonomous Trade Preferences that the EU previously extended to Croatia, providing all Croatian industrial and most agricultural products with free access to the EU market. On January 1, 2002, Croatia also started to extend gradually tariff preferences to the EU, providing free access to 70 percent of the value of EU industrial and agricultural products currently exported to the Croatian market. Since then, Croatia has been adjusting its entire legislative and administrative system in accordance with EU requirements and is currently in the final stage of the EU accession process that started on October 4, 2005 and will presumably conclude on July 1, 2013, once the parliaments of all of the EU member states ratify the Accession Treaty that EU signed with Croatia on December 9, 2011. Web Resources American Chamber of Commerce in Croatia - www.amcham.hr ATA Carnet - http://www.atacarnet.com/ BDVAM-K, d.o.o. (technical regulations consultant) - miroslav.matasovic1@zg.t-com.hr Bureau of Industry and Security - http://www.bis.doc.gov/ Croatian Accreditation Agency - http://www.akreditacija.hr/ Croatian Chamber of Commerce - www.hgk.hr Croatian Customs - http://www.carina.hr/ Croatian Government - http://www.vlada.hr Croatian Official Gazette - http://www.nn.hr/ Catalog of Croatian Standards - http://www.hzn.hr/english/Hrvatske_norme.html Croatian Standards Institute - http://www.hzn.hr/english/indexen.html Delegation of the European Commission to the Republic of Croatia - http://www.delhrv.ec.europa.eu/?lang=en European Commission – Standards and Single Market for Goods and Services - http://ec.europa.eu/enterprise/index_en.htm Ministry of Foreign and European Affairs - http://www.mvpei.hr Ministry of Economy, Labor and Entrepreneurship - http://www.mingorp.hr/ Ministry of Agriculture - http://www.mps.hr/ Ministry of Health - http://www.mzss.hr/ Ministry of Foreign and European Affairs – EU Accession - http://www.eupregovori. hr/ National Institute of Standards and Technology - http://www.nist.gov/index.html NIST Notify U.S. Service - http://www.nist.gov/notifyus/ Quality Superintending Company, Ltd. - http://www.zik.hr/ State Office for Metrology - http://www.dzm.hr/ State Inspectorate - http://www.inspektorat.hr U.S. Mission to the European Union - http://www.buyusa.gov/europeanunion/standards.html